Ramucirumab 8 / Paclitaxel 80, adenocarcinoma esophagogastric junction and stomach

Protocol-ID: 327 V1.2 (Complete), RAMU8/PACL80, AEG/Gastric Ca

Indication(s)

Gastric Cancer; ICD-10 C16.-, C16.0
Esophageal Cancer (Adenocarcinoma of the esophagogastric junction (AEG)); ICD-10 C15.-

Protocol classification

Classification: alternative
Intensity: Standard dose
Therapy mode: Second line
Therapy intention: palliative

Cycles

Cycle length 28 days, recommended cycles: 5

Risks

Emetogenicity (MASCC/ESMO): low (10-30%)
Neutropenia: high (21-40%)
Febrile Neutropenia: low (<10%)
Thrombocytopenia below 50 000/µl: low (<10%)
Anemia Hb below 8g/dl: moderate (6-15%)
Hypertension: CTC AE °1-2: 10%; °3-4: 14%
Proteinuria: CTC AE °1-2: 15%; °3-4: 1%
Fatigue: CTC AE °1-2: 45%; °3-4: 12%
Infusion Reaction: CTC AE °1-2: 5%; °3-4: 1%
Hemorrhage: CTC AE °1-2: 38%; °3-4: 5%
Neuropathy: CTC AE °1-2: 38%; °3-4: 8%

Therapy

Day	Substance	Dosage	Appl.	Inf. time	Procedure
HYD Hydration: Balanced Crystalloid Solution
Access: peripheral venous
Hydration before, during, or after antitumor therapy
1,15	Balanced Crystalloid Solution	500 ml	i.v.	60 min	60 min before Ramucirumab (d1,15)

8	Balanced Crystalloid Solution	500 ml	i.v.	60 min	60 min before Paclitaxel (d8)

Day	Substance	Dosage	Solution	Appl.	Inf. time	Procedure
AP Allergy prophylaxis: Paclitaxel
Access: peripheral venous
Dexamethasone, dimetinden maleate, cimetidine
1,15	Dexamethasone	20 mg	NaCl 0.9% 50 ml	i.v.	5 min	30 min before Ramucirumab (d1,15)
8	Dexamethasone	20 mg	NaCl 0.9% 50 ml	i.v.	5 min	30 min before Paclitaxel (d8)
1,15	Dimetinden	4 mg	NaCl 0.9% 50 ml	i.v.	5 min	30 min before Ramucirumab (d1,15)
8	Dimetinden	4 mg	NaCl 0.9% 50 ml	i.v.	5 min	30 min before Paclitaxel (d8)
1,15	Cimetidine	300 mg	NaCl 0.9% 50 ml	i.v.	5 min	30 min before Ramucirumab (d1,15)
8	Cimetidine	300 mg	NaCl 0.9% 50 ml	i.v.	5 min	30 min before Paclitaxel (d8)

Day	Substance	Dosage	Solution	Appl.	Inf. time	Procedure
CTX Antineoplastic therapy: RAMU8/PACL80
Access: peripheral venous
Ramucirumab/paclitaxel in advanced adeno-Ca of the stomach and adenco-Ca of the gastroesophageal junction.
1,15	Ramucirumab	8 mg/kg bw	NaCl 0.9% 250 ml	i.v.	60 min	Sequence
Maximum infusion rate 25 mg/min.
1,8,15	Paclitaxel	80 mg/m² BSA	NaCl 0.9% 250 ml	i.v.	60 min	Sequence

Concomitant therapy supplements

Dexamethasone for antiemesis and Ramucirumab allergy prophylaxis are covered by Paclitaxel allergy prophylaxis. For infusion reactions, see the respective summary of product characteristics.

Notes

Therapy is continued until progression or the occurrence of unacceptable side effects. In the study, a median of 4.5 cycles were administered (range 2.5-8).

Cycle diagram

Hydration: Balanced Crystalloid Solution

Substance	1	8	15
	Week 1 / d	Week 2 / d	Week 3 / d
Balanced Crystalloid Solution (i.v.)
Balanced Crystalloid Solution (i.v.)

Allergy prophylaxis: Paclitaxel

Substance	1	8	15
	Week 1 / d	Week 2 / d	Week 3 / d
Dexamethasone (i.v.)
Dexamethasone (i.v.)
Dimetinden (i.v.)
Dimetinden (i.v.)
Cimetidine (i.v.)
Cimetidine (i.v.)

Antineoplastic therapy: RAMU8/PACL80

Substance	1	8	15
	Week 1 / d	Week 2 / d	Week 3 / d
Ramucirumab (i.v.)
Paclitaxel (i.v.)

Cycles

Cycle length 28 days, recommended cycles: 5

Controls:

Blood count: on day 1 and subsequently weekly
ECG Risk of developing a conduction disorder during paclitaxel therapy, ECG monitoring every 3 cycles.
Day 1: GOT, GPT, GGT, Bilirubin, AP, Cholinesterase Liver function monitoring before and during paclitaxel therapy, Ramucirumab: liver function monitoring before therapy.
Day 1: Blood pressure Ramucirumab: continuous monitoring before and during therapy
Day 1: Urine protein excretion Ramucirumab: risk of proteinuria during therapy

Pharmacokinetics

Cimetidin: CYP450 Inhibitor, vielschichtige Interaktionen möglich

Original indication

Met. or progressive gastric cancer and adeno-ca of the esophagogastric junction, second line, progression within 4 months after first line, ECOG 0-1

Original author

Wilke H (2014)

Origin

Abteilung für Onkologie/Hämatologie, Kliniken Essen-Mitte, Deutschland, RAINBOW Study Group, RAINBOW Studie

References

Wilke H, Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a double-blind, randomised phase 3 trial. Lancet Oncol 2014 Oct;15(11):1224-35. doi: 10.1016/S1470-2045(14)70420-6. PMID: 25240821. [PMID]

Recommendations

09/2016: European Society for Medical Oncology
06/2021: National Comprehensive Cancer Network

Status

Valid since 2021-07-04, Version 1.2, last updated 2021-07-04

Last modification: V1.2: Protocol name changed V1.1: Cato test done. Revision of allergy prophylaxis according to the SmPC, change of H2- antagonist for Paclitaxel from Ranitidine to Cimetidine according to DGHO recommendations 10/2019. V1.0: Duration and sequence of substances according to primary literature in line with the Ramucirumab SmPC.

Important notice

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